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A strategy for population pharmaceutical quality assessment based on quality by design

From a regulatory perspective, drug quality consistency evaluation must concern different processes used for the same drug. In this study, an assessment strategy based on quality by design (QbD) was developed for population pharmaceutical quality evaluation. A descriptive analysis method based on Qb...

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Autores principales: Zhao, Yu, Hu, Changqin, Yao, Shangchen, Yin, Lihui, Ling, Xiaomei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572710/
https://www.ncbi.nlm.nih.gov/pubmed/34765271
http://dx.doi.org/10.1016/j.jpha.2020.11.001
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author Zhao, Yu
Hu, Changqin
Yao, Shangchen
Yin, Lihui
Ling, Xiaomei
author_facet Zhao, Yu
Hu, Changqin
Yao, Shangchen
Yin, Lihui
Ling, Xiaomei
author_sort Zhao, Yu
collection PubMed
description From a regulatory perspective, drug quality consistency evaluation must concern different processes used for the same drug. In this study, an assessment strategy based on quality by design (QbD) was developed for population pharmaceutical quality evaluation. A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes (CEAs). Then quantitative analysis method based on an improved statistical process control (SPC) method was established to investigate the process indicators (PIs) in the process population, such as mean distribution, batch-to-batch difference and abnormal quality probability. After that rules for risk assessment were established based on the SPC limitations and parameters. Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality. Finally, an assessment strategy was built and applied to generic drug consistency assessment, process risk assessment and quality trend tracking. The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk, and further show the recent development status of domestic pharmaceutical production processes. In addition, a process risk assessment and population quality trend tracking provide data-based information for approval. Not only can this information serve as a further basis for decision-making by the regulatory authority regarding early warnings, but it can also reduce some avoidable adverse reactions. With continuous addition of data, dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.
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spelling pubmed-85727102021-11-10 A strategy for population pharmaceutical quality assessment based on quality by design Zhao, Yu Hu, Changqin Yao, Shangchen Yin, Lihui Ling, Xiaomei J Pharm Anal Original Article From a regulatory perspective, drug quality consistency evaluation must concern different processes used for the same drug. In this study, an assessment strategy based on quality by design (QbD) was developed for population pharmaceutical quality evaluation. A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes (CEAs). Then quantitative analysis method based on an improved statistical process control (SPC) method was established to investigate the process indicators (PIs) in the process population, such as mean distribution, batch-to-batch difference and abnormal quality probability. After that rules for risk assessment were established based on the SPC limitations and parameters. Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality. Finally, an assessment strategy was built and applied to generic drug consistency assessment, process risk assessment and quality trend tracking. The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk, and further show the recent development status of domestic pharmaceutical production processes. In addition, a process risk assessment and population quality trend tracking provide data-based information for approval. Not only can this information serve as a further basis for decision-making by the regulatory authority regarding early warnings, but it can also reduce some avoidable adverse reactions. With continuous addition of data, dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation. Xi'an Jiaotong University 2021-10 2020-11-04 /pmc/articles/PMC8572710/ /pubmed/34765271 http://dx.doi.org/10.1016/j.jpha.2020.11.001 Text en © 2020 Xi'an Jiaotong University. Production and hosting by Elsevier B.V. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Article
Zhao, Yu
Hu, Changqin
Yao, Shangchen
Yin, Lihui
Ling, Xiaomei
A strategy for population pharmaceutical quality assessment based on quality by design
title A strategy for population pharmaceutical quality assessment based on quality by design
title_full A strategy for population pharmaceutical quality assessment based on quality by design
title_fullStr A strategy for population pharmaceutical quality assessment based on quality by design
title_full_unstemmed A strategy for population pharmaceutical quality assessment based on quality by design
title_short A strategy for population pharmaceutical quality assessment based on quality by design
title_sort strategy for population pharmaceutical quality assessment based on quality by design
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572710/
https://www.ncbi.nlm.nih.gov/pubmed/34765271
http://dx.doi.org/10.1016/j.jpha.2020.11.001
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